Biosimilar and Interchangeable Biologics
โ Sarfaraz K. Niazi
๐ Library
๐
2015
๐ CRC Press
๐ English
โฆ LIBER โฆ
๐
Biosimilars and interchangeable biologics: strategic elements
โ Scribed by Niazi, Sarfaraz
- Publisher
- CRC Press
- Year
- 2016
- Tongue
- English
- Leaves
- 632
- Category
- Library
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No coin nor oath required. For personal study only.
โฆ Table of Contents
Content: Introduction to biosimilar and interchangeable products --
Intellectual property issues --
The EMA regulatory guidance --
EMA approved biosimilars --
The FDA regulatory guidance --
The ROW regulatory guidance --
US commercialization --
Global commercialization --
Quality and lifecycle management.
โฆ Subjects
Pharmaceutical biotechnology.;Biopharmaceutics.;Pharmaceutical industry;Technological innovations.;Biologicals.;Biosimilar Pharmaceuticals;standards.;Drug Approval.;Drug Discovery;standards.;Drug Evaluation;standards.;Drug Industry;standards.;BUSINESS & ECONOMICS;Industries;General.
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